23. Quality audit programmes, findings and closure
Govern internal Quality audits from risk-based programme through independently approved plan, evidence-backed fieldwork, immutable reports, corrective-action response, effectiveness verification and closure.
Purpose
Govern internal Quality audits from risk-based programme through independently approved plan, evidence-backed fieldwork, immutable reports, corrective-action response, effectiveness verification and closure.
Quality Audit Manager, different QA Head, separate Internal Auditor, separate Quality Engineer process owner, Supplier Quality/Auditor read-only
AUP-E2E-001 v1 rejected → v2 approved → AUD-E2E-001 plan v1 rejected → plan v2 approved → report v1 rejected → report v2 accepted → response v1 rejected → response v2 effective → linked NCR closed → audit closed.
Before you begin
- One site and CLEAN controlled evidence version exist
- Distinct Quality Audit Manager, QA Head, Internal Auditor and Quality Engineer users are active, site-scoped and cleared
- The audit criteria and sampled process are defined
- A major/minor finding can be connected to a separately governed same-site Flow 13 NCR/CAPA record
Audit independence and corrective-action boundaries
Period, frequency, objectives, scope, criteria, risk basis, classification and evidence are immutable after submission. QA rejection preserves the version and permits a new one.
Each engagement snapshots the approved programme version, scope, objectives, criteria, sampling, dates and two distinct assignments. The manager, lead auditor and process owner must be different users.
Only the assigned Internal Auditor may start and report. The process owner cannot execute their own audit and the Audit Manager cannot act as auditor through this flow.
A report contains completion date, sampled records, conclusion, objective evidence and findings. QA rejection retains it and returns fieldwork for a new report version.
Major and minor nonconformities require a response due date and corrective-action response. Observations and opportunities are retained as no-action findings and do not masquerade as nonconformities.
Every major/minor response links a same-site Flow 13 NCR/CAPA within the audit classification. The audit does not create or close that record automatically.
The process owner records root cause, correction, systemic corrective action, completion, effectiveness criteria and CLEAN evidence. QA rejection preserves it and requires a new immutable version.
Every major/minor finding must be effectively verified and its linked NCR/CAPA must be CLOSED before QA can close the audit. Follow-up need and date remain attributable closure evidence.
No audit route changes current_stock, stock_ledger, supplier approval, item/product configuration or external-message delivery. Findings route work to their authoritative modules.
Procedure
- 1
Create/submit programme v1 as Quality Audit Manager; reject it as QA, then create/submit/approve immutable v2.
- 2
Create/submit plan v1 with distinct lead auditor and process owner; reject it as QA, then create/submit/approve immutable v2.
- 3
Start fieldwork and submit report v1 as the assigned Internal Auditor; reject it as QA, then submit/accept corrected report v2.
- 4
Submit finding response v1 as the assigned process owner; reject it as QA, then submit response v2 and verify it effective.
- 5
Confirm closure is blocked while the linked NCR/CAPA remains open; close that record in Flow 13, then close the audit with evidence and follow-up data.
- 6
Read the complete chain as Auditor and reconcile four-person separation, immutable histories, document links, audit/outbox chronology and zero operational side effects.
Expected result
- Programme lifecycle follows DRAFT → PROGRAMME_REVIEW → ACTIVE
- Audit lifecycle follows DRAFT → PLAN_REVIEW → READY → FIELDWORK → REPORT_REVIEW → RESPONSE_PENDING or CLOSURE_PENDING → CLOSED
- Manager, QA, lead Internal Auditor and process owner are four different user IDs
- Rejected programme, plan, report and response versions remain immutable
- Only accepted current-report findings can receive responses
- Every major/minor finding response links a same-site NCR/CAPA
- An effective verification with UNACCEPTABLE residual risk is rejected
- Audit closure is blocked until every required response is effective and every linked NCR/CAPA is closed
- Supplier Quality and Auditor mutation attempts are rejected
- Quality audit routes never change inventory, supplier approval, product baseline or external delivery state